Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing.

Carl Patterson, M.S. is Keynote Speaker at Compliance key Inc. He has completed twelve (12) plus years in the biotechnology, pharmaceutical manufacturing, and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas. Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master's of Science in Biomedical Quality Systems from SDSU. Through the years, has worked with several companies in regards to aseptic processing and has helped to insure the expectations, r........

The seminar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There are international and federal regulations that describe what aspects should be considered during manufacturing. This webinar will go into detail on those regulations and how they apply to pharmaceutical and biopharmaceutical manufacturing.

Why should you attend this webinar?

The microbial aspect of pharmaceutical / biopharmaceutical manufacturing is a key component of the overall manufacturing process. Understanding this component is vital in ensuring a pharmaceutical product meets the expectations of a regulatory agency. If this component of the manufacturing process is not well understood, consequences to be harmful to the patient and subsequently the company producing the product.

Areas Covered in the Session:

International regulations (ISO)

Federal regulation (FDA, USP)

Room classifications and how applied to manufacturing

Auditing company environmental programs for effectiveness

Reviewing of documents in relation to microbial aspects

Sources of common microorganisms

Identify root causes for many microbiological excursions

Who can Benefit:

All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where microbiological aspects are monitored and reported.